IRB Connection HSO Newsletter

Please pass this newsletter along to others who may be interested in signing up to receive this newsletter and other notices from the Human Subjects Office or IRB. If you are interested in signing up for the listserv, send an email to In the body of the message include the following:


Subscribe IRBNEWS yourfirstname yourlast name

Example: subscribe IRBNEWS John Smith

You will receive a confirmation message via email when you have been added. You must respond to this message in order for your membership to become active. 

If you have questions regarding the content of the newsletter, please contact the IRB Education and Compliance Program at

Share your ideas! Please email your comments, suggestions, newsletter topics, and research experiences to The HSO is looking for research team members, studies, awards and stories to feature in upcoming issues of the HSO newsletter.



  • "I didn't think it was Human Subjects Research because..."
  • UI policy on Mandatory Reporting of Physical and Sexual Abuse of Children: The Research Perspective
  • Conflict of Interest in Research-Implications for Investigators



  • External IRBs incorporated into HawkIRB
  • Financial Interest Disclosure Reporting
  • News Flash


  • Financial Conflict of Interest in Research
  • Upcoming AAHRPP Site Visit
  • Subjects Who Are Lost to Follow-up
  • News Flash: HSO Interim Director appointment and staff departures


  • Keeping Current on International Research Regulations
  • Tips to Improve your Informed Consent Document
  • Mainline Questions: HawkIRB Workflow


  • Facebook's Controversial Sociological Study
  • A personal Note from the HSO director
  • Need help with HawkIRB? Herky Hints: Oops, I Made this Draft... Now What?
  • New Positions filled in the Human Subjects Office!


  • Research Misconduct, Prevention Strategies and More
  • Changes in IRB Determinations for Studies that Access PHI for Recruitment
  • Did You Know? – HSO Presentations
  • Who Should Be a Research Team Member?
  • Try Your Hand at Being an IRB Chair


  • A More Flexible IRB on the Horizon
  • Tips to Protect and Secure Information When Using Mobile Devices
  • News Flash: Relocation of the Conflict of Interest in Research Program
  • Need help with HawkIRB?  Herky Hints: Assurance Document


  • IRB Review of Qualitative Research – Just Jumping Through the Hoops?
  • A Change in Your Summer Plans? - Let us Know!
  • News Flash: HSO Staff Farewell
  • Need help with HawkIRB? Herky Hints: Dealing with HawkIRB email notifications

April - Research with Children Special Edition

  • Risk and IRB Review
  • Assent
  • Parental Permission  
  • Applicable Regulatory Definitions
  •  HawkIRB: Procedures for Obtaining Consent and Assent
  • Pregnancy in a Minor Subject Population


  • Describing Risk to Research Participants
  • Disclosing the Probability and Magnitude of Physical Risk
  • What We Did Last Month...Submitted an application for AAHRPP Re-Accreditation
  •  News Flash: Changes with HawkIRB and the CRU
  • This month in Human Subjects Protection History: The Belmont Report


  • Additional Requirements for DoD Research
  • Where is this CITI of which you speak, and what does it have to do with me?
  • Spring Break Reminder (submit your HawkIRB application/HSRD)
  • IRB Policy Revision: Revised Guidelines Regarding Payment and Compensation
  • What’s that Mean?: Certified IRB Professional


  • New Compliance Monitoring Programs Coming to a Study Near You​
  • News Flash: HSO New Hours of Operation
  • IRB Policy Revision: Inclusion of Compensation Amount in Recruitment Materials
  • IRB Policy Reminder: Cold-Calling of Potential Subjects as a Recruitment Method​

January - Reportable Events Special Edition (IRB-01/03) 
January - Reportable Events Special Edition (IRB-02) 

  • What are Reportable Events?
  • Serious Adverse Drug Events (IRB-01/03)
  •  Serious Adverse Device Effect (IRB-01/03)
  •  Reportable Events Q&A: Why do I need to submit REFs?
  • Receipt of New Information
  • Unanticipated Problems Involving Risks to Subjects or Others
  • Noncompliance
  • Preventing Reportable Events


  • Letter from the Editor
  •  Should I Submit a New Project Application or a Modification?
  • News Flash: Andy Bertolatus' retirement announcement
  • Back to School Reminder: Submit your HawkIRB Application



  • Why is My Study Going to the Full Board?
  • Come to the Dark Side, we have cookies! (Working for the HSO)
  • What's that Mean?: Human Subjects Research Acronyms
  •  HawkIRB: How Do I Use the Inbox Filter?


  • The Informed Consent Process
  • Mainline Questions: Flavors of Waivers
  • Use of Short Form Consent Document for Non-English Speaking Subjects
  • Obtaining Required Signatures on the Informed Consent Document


  • Coercion and Undue Influence: What is the difference?
  • Mainline Questions: Alphabet Soup (HSO vs. IRB)
  • HawkIRB: How Do I Use the Delegate Permission System?
  • IRB Policy Reminder: Requirements for Completion of Optional Agreements


  • Mainline Questions: What does Exempt mean?
  • The Mailed Consent Process: What to do if there are errors?
  • Back to School: Human subjects research in the classroom
  • News Flash: Course-Related Student Project Policy Revision
  • IRB Policy Reminder: UI Students as Research Subjects


  • Enrolling Minors: What Happens When They Age Up?
  • HIPPA/HITECH Act Omnibus Final Rule
  • Human Subjects Research Data and Sample Identification Terms
  • IRB Policy Reminder: Case Report Forms (CRFs) Should not be attached to the HawkIRB Application
  • Have an idea for IRB Connection?

July- Genetic Research Special Edition

  • Federal Regulations and Guidance
  • Genetic Information Nondiscrimination Act (GINA)
  • Is it Genetic Research?
  • Incidental Findings


  • Top 5 Monitoring Findings of 2012
  • Mainline Questions: Do I have to fill out an IRB application?
  • HawkIRB: How do I find my Approval Memo?
  • Get to Know: The HSO Exec. Director and UI Institutional Official
  • News Flash: My Research Portal


  • Greetings from the HSO: Mainline Questions
  • New FDA Rule: Children in Clinical Investigations
  • IRB Policy: Compensation in Recruitment Materials
  • Get to Know: The Education and Compliance Staff


  • Plain Language Facilitating Subjects Understanding
  • Revisions to the Declaration of Helsinki
  • IRB Policy Reminder: Recording Additional Information on the Informed Consent Document
  • Issues to Consider when a PI leaves the UI
  • Get to Know: The IRB-02 Staff